This month's "MS — The Practical Art" will interest those starting a new good laboratory practices (GLP) bioanalytical laboratory, reassessing an existing laboratory, or revamping a "spirit-of-GLP" laboratory to full GLP status. Historically, mass spectrometers have been used largely in drug discovery owing to their qualitative capabilities and have escaped rigorous regulation. This is clearly no longer the case. Mass spectrometers are used increasingly as primary detectors in all facets of operations, which led to a column in 2004 exploring the changing nature of validation: "Taming the Regulatory Beast: Regulation Versus Functionalism" (1).

Many firms conducting internal accounting analyses find that performing GLP bioanalyses internally (as opposed to outsourcing them to contract laboratories) saves time and money. This economic efficiency is particularly true for large-sample-number studies because pricing tends to be based upon a per-sample method.

The principle rarely extends to contract laboratories performing small-sample-number studies, however, because smaller numbers of samples often lack profit potential. Consequently, those laboratories sometimes delay a sponsor's small-sample-number studies or assign them a lower priority. This frustrates pharmaceutical sponsors because early studies, no matter how small, can be time-critical, as in the case of toxicology studies.

Sidebar I: Seven major categories of work for the validation master plan

We recommend treating a spirit-of-GLP laboratory as you would a non-GLP laboratory to convert it to full GLP status. To begin constructing a new GLP facility, we suggest you first put into effect a master plan (Sidebar I). The master plan should address these major categories of work, with each category assigned its own manager and allocated its own resources:

• Standard operating procedures
• Installation, operational, and performance qualification (IQ, OQ, and PQ, respectively) of facilities, instrumentation, and software
• Personnel selection, staffing, and training
• Quality control (QC) procedures and staffing
• Quality assurance
• Procedures and staffing
• Documentation and archival process
• Final gap analysis.